DIVALPROEX SODIUM tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIVALPROEX SODIUM (UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

DIVALPROEX SODIUM

Composition:

VALPROIC ACID 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Divalproex sodium is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder. A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. The efficacy of divalproex sodium was established in 3 week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania [see Clinical Studies (14.1)] . The safety and effectiveness of divalproex sodium for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use divalproex sodium for extended periods should continually reevaluate the long-term usefulness of the drug for the individual patient. Divalproex sodium delayed-release tablets are indicated as monothe

Product summary:

Divalproex Sodium Delayed-release Tablets, USP equivalent to 125 mg of valproic acid, are white to off-white having mottled spots, oval shaped, enteric-coated tablets with the logo of "ZA08" on one side and plain on other side. Divalproex Sodium Delayed-release Tablets, USP equivalent to 250 mg of valproic acid, are white to off-white having mottled spots, oval shape, convex, enteric-coated tablets imprinted with the logo of "ZA07" on one side and plain on other side and are supplied as follows: NDC 0615-7849-39 in blistercards of 30 tablets NDC 0615-7849-30 in unit-dose boxes of 30 tablets Divalproex Sodium Delayed-release Tablets, USP equivalent to 500 mg of valproic acid, are white to off-white having mottled spots, oval shape, beveled edge, convex enteric-coated tablets imprinted with the logo of "ZA06" on one side and plain on other side and are supplied as follows: NDC 0615-7850-39 in blistercards of 30 tablets NDC 0615-7850-30 in unit-dose boxes of 30 tablets Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
NCS HealthCare of KY, Inc dba Vangard Labs
----------
MEDICATION GUIDE
Divalproex Sodium
(dye val PRO ex sew dee uhm)
Delayed-release Tablets, USP
Read this Medication Guide before you start taking divalproex sodium
and each time you get a refill.
There may be new information. This information does not take the place
of talking to your healthcare
provider about your medical condition or treatment.
What is the most important information I should know about divalproex
sodium?
Do not stop divalproex sodium without first talking to your healthcare
provider.
Stopping divalproex sodium suddenly can cause serious problems.
Divalproex sodium can cause serious side effects, including:
1. Serious liver damage that can cause death, especially in children
younger than 2 years old.
The risk of getting this serious liver damage is more likely to happen
within the first 6 months of
treatment.
Call your healthcare provider right away if you get any of the
following symptoms:
•
nausea or vomiting that does not go away
•
loss of appetite
•
pain on the right side of your stomach (abdomen)
•
dark urine
•
swelling of your face
•
yellowing of your skin or the whites of your eyes
In some cases, liver damage may continue despite stopping the drug.
2. Divalproex sodium may harm your unborn baby.
•
If you take divalproex sodium during pregnancy for any medical
condition, your baby is at risk for
serious birth defects. The most common birth defects with divalproex
sodium affect the brain and
spinal cord and are called spina bifida or neural tube defects. These
defects occur in 1 to 2 out of
every 100 babies born to mothers who use this medicine during
pregnancy. These defects can
begin in the first month, even before you know you are pregnant. Other
birth defects can happen.
•
Birth defects may occur even in children born to women who are not
taking any medicines and do
not have other risk factors.
•
Taking folic acid supplements before getting pregnant and duri

Summary of Product characteristics

DIVALPROEX SODIUM- DIVALPROEX SODIUM TABLET, DELAYED RELEASE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DIVALPROEX SODIUM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR DIVALPROEX SODIUM.
DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1983
WARNINGS: LIFE THREATENING ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
HEPATOTOXICITY, INCLUDING FATALITIES, USUALLY DURING THE FIRST 6
MONTHS OF TREATMENT. CHILDREN UNDER THE
AGE OF TWO YEARS AND PATIENTS WITH MITOCHONDRIAL DISORDERS ARE AT
HIGHER RISK. MONITOR PATIENTS CLOSELY,
AND PERFORM SERUM LIVER TESTING PRIOR TO THERAPY AND AT FREQUENT
INTERVALS THEREAFTER (5.1)
FETAL RISK, PARTICULARLY NEURAL TUBE DEFECTS, OTHER MAJOR
MALFORMATIONS, AND DECREASED IQ (5.2, 5.3, 5.4)
PANCREATITIS, INCLUDING FATAL HEMORRHAGIC CASES (5.5)
INDICATIONS AND USAGE
Divalproex sodium delayed-release tablets are anti-epileptic drug
indicated for:
Treatment of manic episodes associated with bipolar disorder (1.1)
Monotherapy and adjunctive therapy of complex partial seizures and
simple and complex absence seizures; adjunctive
therapy in patients with multiple seizure types that include absence
seizures (1.2)
Prophylaxis of migraine headaches (1.3)
DOSAGE AND ADMINISTRATION
Divalproex sodium delayed-release tablets are administered orally in
divided doses Divalproex sodium delayed-release
tablets should be swallowed whole and should not be crushed or chewed
(2.1, 2.2).
Mania: Initial dose is 750 mg daily increasing as rapidly as possible
to achieve therapeutic response or desired plasma
level (2.1). The maximum recommended dosage is 60 mg/kg/day (2.1,
2.2).
Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1
week intervals by 5 to 10 mg/kg/day to achieve
optimal clinical response; if response is not satisfactory, check
valproate plasma level; see full prescribing information
for co